At my work in IVD companies we also had the same where we had bench top equipment sold with a UPS as an option. We did not perform any electrical safety or other type of testing on the UPS device because 1) it was an optional accessory - not required to run the equipment and 2) the device had already all the testing performed. We did purchase these UPS battery back-ups, kept in inventory, and sold as part of the finished device. In the incoming inspection, we only verified the part number/model number, and most UPS come with a QC testing receipt. But definitely we check at incoming receiving to make sure we had the correct product, because there can be different versions of UPS. However, we did not perform any testing of the incoming unit, never did any type of "burn in", and also never tested anything as part of development. This was considered an Off The Shelf item we provided to our end customers as an option if they already did not have a UPS. In our User Manual we strongly recommended use of a UPS because some of our IVD tests required a couple hours to run. Never want to be at 1:48 minutes in the test sequence and the power goes out and instrument shuts off ! Just keep in mind your last question about is there FDA or hospital requirements for power supplies? The answer to that is yes. Is there FDA or hospital requirements for UPS systems? There is none of FDA and some hospitals may internally require a UPS. Power supplies providing electrical power to an instrument is different from a UPS that conditions a line or provides battery back up in case of power cut. We had in our technical information the type of UPS we recommended and provided to our customers based on the power draw of our instrument.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 12-Aug-2019 16:25
From: Anonymous Member
Subject: Electrical accessories - Universal Power supply (UPS) Line Conditioner
This message was posted by a user wishing to remain anonymous
Hello,
We sell clinical diagnostic lab equipment with a line conditioner (UPS) as an option during installation in case the lab doesn't already have one. As someone relatively new to electrical medical equipment, I'm not sure what the risk level is for the UPS product. As the product is provided to the customer for specific use with our IVD device, I am on the side of implementing quality system controls including a product specification/incoming inspection. The main reasons would be to ensure we received the correct product and to ensure that the correct specifications were known if we ever had to switch models/vendors. Are there FDA or hospital requirements for power supplies?
This question is aimed at the US market only.
Thank you for your feedback.